Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Key responsibilities:
Quality Control (QC) Associate to support Contract Drug Manufacturing Organization and Contract Labs for the applicable programs. This position will work closely with QC, Quality, and other departments to manage data and documents. This position will support QC activities, data review, document management, and maintain content aligns with source documentation.
Supports QC point of contact for CDMO and CTL associated with QC test results
Participates in cross functional workstreams in analytical data review
Updates scheduling/planning/TAT of test results from CTL and CDMO
Maintains spreadsheets via data entry and verification of data review
Collaborates with internal stakeholders to retrieve information
Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies
Identify risks and gaps with documentation
Create and format datasets, memos, and reports as needed
Education and Experience:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
OR Masters degree
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Experience in the pharmaceutical industry, biotech industry, life sciences industry and understanding of drug development process in cGMP setting.
Experience with creating/revising documents in an electronic document management system
Complete projects according to outlined scope, budget, and timelines
Proficiency in Microsoft Word/Excel and Smartsheet
Demonstrate success in a fast-paced, multi-tasking environment
Detail-oriented
Strong written and verbal communication skills
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
